WO2024114407A1

WO2024114407A1 - Thrombus extraction sheath tube assembly

Info

Publication number: WO2024114407A1
Application number: PCT/CN2023/132275
Authority: WO
Inventors: 刘全祖; 王泽洋
Original assignee: 先健科技(深圳)有限公司
Priority date: 2022-11-28
Filing date: 2023-11-17
Publication date: 2024-06-06

Abstract

Provided is a thrombus extraction sheath tube assembly (10), comprising a sheath tube (200) and a sheath core (100). The sheath core (100) is arranged in the sheath tube (200) in a penetrating manner. A distal end portion of the sheath tube (200) is provided with a collection net (210). The sheath tube (200) is provided with a net storage section (120) for accommodating the collection net(210). According to the thrombus extraction sheath tube assembly (10), surrounding blood vessels are sealed by means of the collection net (210), such that the case where a thrombus is scoured by blood flow and then falls off during thrombus extraction is avoided, and the risk that the thrombus is retained outside the sheath tube (200) can be effectively avoided, thereby improving an operation success rate, and avoiding other unnecessary complications. Meanwhile, the net storage section (120) is configured for accommodating the collection net (210) in the process of placing the thrombus extraction sheath tube assembly (10) in a blood vessel, such that the thrombus extraction sheath tube assembly (10) can conveniently penetrate into the blood vessel.

Description

Plug removal sheath tube assembly

Technical Field

The invention belongs to the technical field of medical devices, and in particular relates to an embolism removal sheath tube assembly.

Background technique

Thrombi are small pieces of blood formed on the surface of the peeling or repairing of the cardiovascular system's endothelial membrane, including insoluble fibrin, deposited platelets, accumulated white blood cells and trapped red blood cells. When thrombi are located in the neurovascular system, they may cause strokes; when thrombi are located in the pulmonary vascular system, they may cause pulmonary embolism; when blockages such as atherosclerosis and its plaques restrict blood flow, they may also become more dangerous, causing abnormal blood flow and causing various vascular diseases.

At present, the main methods for treating thrombosis include drug antithrombotic therapy and artificial mechanical methods to physically restore blood vessel patency. Mechanical thrombus removal devices are a group of instruments used to remove blockages in blood vessels. They use dissolution, crushing, suction, stents or basket thrombectomy to remove blockages such as thrombi and plaques in blood vessels to restore blood circulation function.

As for the stent thrombectomy method, the traditional method is to use a sheath tube in combination with a stent to remove the thrombus. When the stent pulls the thrombus into the sheath tube, the thrombus is prone to fall off due to the small entrance of the sheath tube and blood flow flushing. In order to solve the above problems, the prior art improves the sheath tube and adds a balloon at the head end of the sheath tube to block it, thus preventing the thrombus from being flushed by the blood flow and falling off. However, there is still a risk of the thrombus being retained outside the sheath tube due to the small entrance of the sheath tube.

Therefore, a new technical means is needed to solve the above problems.

Summary of the invention

The purpose of the present invention is to at least solve the problems of low suction rate and easy blockage of the suction cavity of the existing thrombus removal sheath.

The present invention proposes an embolus removal sheath tube assembly, which comprises a sheath tube and a sheath core, wherein the sheath core is inserted into the sheath tube, a collecting net is arranged at the distal end of the sheath tube, and a net storage section for accommodating the collecting net is arranged on the sheath tube.

The thrombus removal sheath tube assembly in the present invention seals the surrounding blood vessels through the collecting net to prevent the thrombus from being washed away by the blood flow when the thrombus is extracted, which can effectively solve the risk of the thrombus being retained outside the sheath tube, improve the success rate of the operation, and avoid other unnecessary complications. At the same time, a net storage section is provided at the distal end of the sheath tube, and the net storage section is used to accommodate the collecting net during the process of inserting the thrombus removal sheath tube assembly into the blood vessel, so as to facilitate the penetration of the thrombus removal sheath tube assembly into the blood vessel. In addition, since the collecting net is provided at the distal end of the sheath tube and the collecting net is accommodated by the net storage section, the outer sheath design can be eliminated, thereby reducing the number and volume of the tubular parts that penetrate the blood vessel, and the suction area of the sheath tube suction cavity can be guaranteed, effectively improving the suction efficiency.

In addition, the embolus removal sheath tube assembly according to the present invention may also have the following additional technical features:

In some embodiments of the present invention, the proximal end of the collecting net is closed and fixedly connected to the distal end of the outer sheath, and the distal end of the collecting net is open.

In some embodiments of the present invention, the collection net comprises a net body with shape memory performance and a covering member disposed on the net body, wherein the covering member covers Cover the mesh holes of the net body.

In some embodiments of the present invention, a tail piece is provided at the proximal end of the sheath tube, and the tail piece includes a control piece for adjusting the posture of the collecting net.

In some embodiments of the present invention, the tail end piece further includes a control rod and a catheter seat connected to the proximal end of the control rod, the control piece is disposed on the control rod and connected to the sheath tube, and the sheath tube passes through the control rod and is connected to the catheter seat.

In some embodiments of the present invention, the catheter hub is provided with a suction port for connecting to an external negative pressure component and an inner sheath hemostatic valve.

In some embodiments of the present invention, the sheath tube includes an inner tube and an outer tube sleeved outside the inner tube, the inner tube and the outer tube can move relative to each other in the axial direction, the collecting net is arranged at the distal end of the inner tube, and the net storage section is arranged on the inner side of the distal end of the outer tube; the control member is used to control the relative movement of the inner tube and the outer tube.

In some embodiments of the present invention, the control member includes a knob rotatably connected to the control rod, the outer tube is fixedly connected to the control rod, the inner tube is threadedly connected to the knob, and the inner tube passes through the outer tube and is slidably connected to the catheter seat; or

The control member comprises a knob rotatably connected to the control rod, the outer tube is fixedly connected to the knob, the inner tube is threadedly connected to the outer tube, and the inner tube passes through the outer tube and is slidably connected to the catheter seat; or

The control member includes a sliding knob slidably connected to the control rod, the outer tube is fixedly connected to the sliding knob, the inner tube is slidably connected to the outer tube, and the inner tube passes through the The outer tube is fixedly connected to the catheter seat.

In some embodiments of the present invention, the network storing section includes an annular groove body arranged on the inner side of the distal end of the outer tube.

In some embodiments of the present invention, a control wire is passed through the sheath, one end of the control wire is connected to the collecting net, and the other end of the control wire is connected to the control member, and the control member adjusts the shape of the collecting net through the control wire.

In some embodiments of the present invention, the control member includes a knob rotatably connected to the control rod and a control block, the control block is threadedly connected to the knob and slidably connected to the control rod, one end of the control wire is connected to the control block, and the sheath is fixedly connected to the control rod; or

The control member comprises a sliding knob slidably connected to the control rod, one end of the control wire is connected to the control block, and the sheath is fixedly connected to the control rod.

In some embodiments of the present invention, the axial length of the collecting net is less than or equal to the radius of the inner diameter of the sheath tube; or the axial length of the collecting net is greater than the radius of the inner diameter of the sheath tube, and the hardness of the control wire is greater than the hardness of the collecting net.

In some embodiments of the present invention, the network hiding section includes an annular groove body arranged on the inner side of the distal end of the sheath tube, a control cavity is arranged in the tube wall of the sheath tube, and the control wire is inserted into the control cavity.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a schematic diagram of the overall structure of an embolism removal sheath tube assembly in Embodiment 1 of the present invention;

FIG2 is a schematic diagram of the structure of a sheath tube in Embodiment 1 of the present invention;

FIG3 is a schematic diagram of the structure of the sheath core in Embodiment 1 of the present invention;

Fig. 4 is a cross-sectional view of the A-A portion of Fig. 1 in the first embodiment of the present invention;

Fig. 5 is a cross-sectional view of the B-B portion of Fig. 3 in the first embodiment of the present invention;

FIG6 is a schematic diagram of the structure of the collecting net after being released from the net storage section in the first embodiment of the present invention;

FIG7 is a schematic diagram of the overall structure of the embolism removal sheath tube assembly in the second embodiment of the present invention;

FIG8 is a partial structural schematic diagram of the collecting net after being released from the outer sheath in the second embodiment of the present invention;

9 is a schematic diagram of the sheath-core structure including the network-hiding section in Embodiment 2 of the present invention;

10 is a schematic diagram of the structure of the sheath tube in Example 2 of the present invention;

11 is a schematic diagram of the structure of the outer sheath in Example 2 of the present invention;

12 is a schematic diagram of the sheath-core structure without a network-hiding segment in Embodiment 2 of the present invention;

13 is a schematic diagram of the assembly structure of the outer sheath and the outer sheath hemostatic valve in Embodiment 3 of the present invention;

14 is a schematic diagram of the developing structure of the collecting network in the third embodiment of the present invention;

FIG15 is a schematic diagram of the overall structure of the embolism removal sheath tube assembly in Embodiment 3 of the present invention;

FIG16 is a schematic diagram of the overall structure of the collecting net after being released from the net storage section in the third embodiment of the present invention;

17 is a schematic diagram of the overall structure of the embolism removal sheath tube assembly in the fourth embodiment of the present invention;

FIG18 is a cross-sectional view of the C-C portion of FIG17 in Embodiment 4 of the present invention;

FIG19 is a schematic diagram of the structure of the network segment after filling in the fourth embodiment of the present invention;

20 is a schematic diagram of the structure of the network segment in a trumpet shape in the fourth embodiment of the present invention;

FIG. 21 is a schematic diagram of the structure of a cover member disposed on the grille body in the fourth embodiment of the present invention.

FIG22 is a schematic diagram of the overall structure of the embolism removal sheath tube assembly in Embodiment 5 of the present invention;

FIG23 is a schematic diagram of the structure of the sheath tube in Embodiment 5 of the present invention;

FIG24 is a schematic diagram of the internal structure of the sheath tube in Embodiment 5 of the present invention;

FIG25 is a schematic structural diagram of another embodiment of the fifth embodiment of the present invention when the inner tube is threadedly connected to the knob;

FIG26 is a schematic structural diagram of another embodiment of the fifth embodiment of the present invention when the outer tube is fixedly connected to the sliding button;

27 is a schematic structural diagram of another embodiment of the fifth embodiment of the present invention when an outer sheath is sleeved outside the sheath tube;

FIG28 is a schematic diagram of the overall structure of the embolism removal sheath tube assembly in Embodiment 6 of the present invention;

FIG29 is a schematic diagram of the internal structure of the sheath tube in Embodiment 6 of the present invention;

30 is a schematic diagram of the structure when three groups of control wires are inserted into the sheath tube in Embodiment 6 of the present invention;

31 is a schematic diagram of the structure when four groups of control wires are inserted into the sheath tube in Embodiment 6 of the present invention;

FIG32 is a schematic structural diagram of another implementation of Example 6 of the present invention when the control wire is fixedly connected to the sliding button;

33 is a schematic diagram of the structure of the collection network when it is accommodated in the network storage section in the sixth embodiment of the present invention;

The reference numerals in the accompanying drawings represent the following:
10. embolus removal sheath tube assembly; 100. sheath core; 110. guide head; 120. net storage section;
121, net cover; 122, net cavity; 123, proximal net section; 124, distal net section; 130, annular groove; 140, guide wire cavity; 150, operating handle; 160, fixing member; 161, first threaded portion; 200, sheath; 210, collecting net; 211, net body; 212, covering member; 213, braided wire; 214, closing end; 215, open end; 220, tail end member; 221, instrument inlet; 222, suction port; 223, first connecting portion; 224, control rod; 225, control member; 2251, knob; 2252, slide button; 2253, control block; 22 6. Catheter seat; 227. Guide part; 2271. Guide block; 2272. Guide groove; 228. Control wire; 229. Control cavity; 230. Inner sheath hemostatic valve; 240. Positioning piece; 260. Locking piece; 270. Suction cavity; 280. Inner tube; 281. Connecting tube; 290. Outer tube; 291. Threaded connection; 300. Outer sheath; 310. Outer sheath hemostatic valve; 311. Second threaded part; 320. Development structure; 321. First development point; 322. Development ring; 323. Second development point; 330. Socket; 340. Second connection; 350. Extension tube; 351. Locking connection.

Detailed ways

The exemplary embodiments of the present application will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present application are shown in the accompanying drawings, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present application and to fully convey the scope of the present application to those skilled in the art.

It should be understood that the terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. The singular forms "a", "an", and "the" used in the description may also be intended to include the plural forms. The terms "include", "comprise", "contain", and "have" are inclusive, and thus specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or combinations thereof.

Although the terms first, second, third, etc. may be used herein to describe multiple elements, components, regions, layers, and/or sections, these elements, components, regions, layers, and/or sections should not be limited by these terms. These terms may only be used to distinguish one element, component, region, layer, or section from another region, layer, or section. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms do not imply a sequence or order when used herein.

For ease of description, spatially relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figures, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figures.

For ease of description, the following description uses the terms "proximal" and "distal", where "proximal" refers to the end close to the operator and "distal" refers to the end away from the operator. The phrase "axial direction" should be understood in this patent to mean the direction in which the interventional element is pushed in and out, and the direction perpendicular to the "axial direction" is defined as the "radial direction".

Embodiment 1

Embodiment 1 of the present invention provides a thrombus removal sheath tube assembly 10, wherein the thrombus removal sheath The structure of the tube assembly 10 is shown in FIGS. 1 to 6 , and please refer to FIGS. 1 to 3 , which include a sheath core 100 and a sheath tube 200. The sheath core 100 is inserted into the sheath tube 200, and a collection net 210 is provided at the distal end of the sheath tube 200. The collection net 210 is used to intercept thrombi to prevent the broken thrombi that have not been successfully aspirated from entering the downstream branch blood vessels during the thrombus aspiration process, causing secondary embolism. The distal end of the sheath core 100 is provided with a net storage section 120 for accommodating the collection net 210. During the process of inserting the sheath tube into the blood vessel, the collection net 210 is accommodated in the net storage section 120. After the sheath core 100 moves to the target position, the collection net 210 is released from the net storage section 120.

As shown in FIG. 4 and FIG. 5 , the net-hiding section 120 includes a net-hiding cover 121 connected to the sheath core 100, the net-hiding cover 121 is sleeved on the outside of the sheath core 100, and a net-hiding cavity 122 for accommodating the collection net 210 is formed between the net-hiding cover 121 and the sheath core 100. A guide head 110 is provided at the front end of the sheath core 100, and the net-hiding cover 121 is connected to the proximal end of the guide head 110. The distal end of the guide head 110 is conically arranged, and its guiding function during the process of the sheath core 100 penetrating the blood vessel improves the passability of the sheath core 100.

Specifically, the net cover 121 is cylindrical and coaxially arranged with the sheath core 100, the distal end of the net cover 121 is fixedly connected to the guide head 110, and the proximal end of the net cover 121 is open. The net cover 121 and the guide head 110 are integrally formed or separately formed and then fixed.

In other embodiments, the aperture of the proximal opening of the net cover 121 is larger than the aperture of the distal end of the net cover 121, that is, the net cavity 122 is set in a conical trumpet-shaped opening. Through the above arrangement, the collection net 210 is more easily released from the net cavity 122, providing convenience for surgical operations.

The sheath core 100 is provided with a guidewire lumen 140 that axially penetrates the sheath core 100. The guidewire lumen 140 is used for inserting a guidewire (the guidewire is not shown in the figure). The guidewire lumen 140 is coaxially arranged with the sheath core 100. The guidewire is used to establish a path for the sheath core 100 before the sheath core 100 enters the human body lumen. The sheath core 100 gradually penetrates into a human lumen, such as a blood vessel, along the guide wire, and pushes the collection net 210 to a location where a thrombus or plaque is present in the human lumen, or other preset target locations.

As shown in FIG2 , the collection net 210 includes a net body 211 and a cover 212 disposed on the net body 211. The cover 212 is used to close the mesh of the net body 211, thereby sealing the blood flow to block the thrombus. Specifically, the cover 212 is a film structure coated or sutured on the net body 211. The cover 212 can be made of materials such as silicone, polyethylene (PE), polyurethane, and nylon.

The covering member 212 may be a film structure that completely covers the net body 211, or the covering member 212 may be a film structure that partially covers the net body 211. When the covering member 212 is a film structure that completely covers the net body 211, the collection net 210 can better block blood to prevent the broken thrombus that has not been successfully aspirated from being washed to the downstream branch vessels by blood, thereby causing embolism of the downstream branch vessels. When the covering member 212 is a film structure that partially covers the net body 211, the part of the net body 211 that is not provided with a film allows blood to circulate, so as to prevent adverse consequences caused by long-term non-flow of blood during surgery.

The net body 211 includes a metal net with shape memory function, which is woven into shape by braiding wires 213. Specifically, the braiding wires 213 are memory metal wires, such as nickel-titanium wires, and the braiding wires 213 are woven into shape and then heat-treated. The proximal end of the collection net 210 is connected to the sheath core 100, and the proximal end of the collection net 210 is closed and the distal end is open, forming a trumpet structure.

As shown in FIG. 6 , when the collecting net 210 reaches the predetermined position, the sheath tube 200 is withdrawn, or the sheath core 100 is pushed forward, so that the collecting net 210 is released from the net storage section 120 . The collection net 210 automatically pops open under the elastic restoring force of the net body 211 to seal the surrounding blood vessels, preventing the thrombus from being washed away by the blood flow when the thrombus is removed. This can effectively solve the risk of thrombus retention outside the sheath 200, improve the success rate of the operation, and avoid other unnecessary complications.

The proximal end of the sheath tube 200 is provided with a tail piece 220, the distal end of the tail piece 220 is connected to the sheath tube 200, and the proximal end of the tail piece 220 is provided with an instrument inlet 221. During assembly, the sheath core 100 is inserted into the sheath tube 200 from the instrument inlet 221 of the sheath tube 200. A suction port 222 is provided on one side of the tail piece 220, and the suction port 222 is used to connect an external negative pressure component, such as a negative pressure pump or a syringe, etc., and the thrombus is extracted from the blood vessel through the inner cavity of the sheath tube 200 through the negative pressure component. Among them, the suction port 222 can also be used as a flushing port, and a first connecting portion 223 is provided on the suction port 222, and the first connecting portion 223 is used to be connected and fixed with the negative pressure component. In this embodiment, the first connecting portion 223 is provided at the end of the suction port 222.

The hollow inner cavity of the sheath tube 200 is used as a sheath core insertion cavity, a flushing cavity and a suction cavity at the same time.

On the one hand, this solution can remove the thrombus by thrombus aspiration, and on the other hand, it can be removed by cooperating with a stent to remove the thrombus. Specifically, when thrombus aspiration is used, the assembled sheath assembly is used to enter the human body. After reaching the designated part, the sheath core 100 is pushed forward to release the collection net 210. After the collection net 210 is released from the net storage section 120 of the sheath core 100, it automatically opens under the action of its own elastic restoring force, and contacts the inner wall of the blood vessel to seal the blood vessel, thereby preventing the thrombus from falling off. It can also avoid that broken thrombi are not successfully aspirated during thrombus aspiration, resulting in secondary embolism of downstream branch vessels. The sheath core 100 is then withdrawn, and the external negative pressure component is connected through the suction port 222 of the tail piece 220, and the negative pressure component is used to perform Aspiration of thrombus: Since the distal end of the sheath tube 200 is provided with a collection net 210, the broken thrombus can be blocked during the aspiration process to ensure the successful implementation of the operation.

When the stent thrombus removal method is adopted, the assembled sheath assembly is inserted into the human body, and after reaching the designated part, the sheath core 100 is pushed forward to release the collection net 210, and then the sheath core 100 is withdrawn, and the stent thrombus removal is performed. Since the collection net 210 is provided at the distal end of the sheath tube 200, when the stent pulls the thrombus into the sheath tube 200, the risk of the thrombus being retained outside the sheath tube 200 due to the small entrance of the sheath tube 200 can be prevented.

In other embodiments, the cover 212 may not be provided on the net body 211 of the collection net 210, and the net body 211 is formed into a densely woven net by densely weaving the woven wires 213, and the maximum pore size of the densely woven net is not greater than 1 mm. Therefore, after the collection net 210 is unfolded, it can not only intercept thrombi but also ensure blood circulation, and for patients with special diseases, the safety of the operation can be guaranteed. Since thrombi can be dissolved naturally or accelerated by drugs, when a collection net in the form of a densely woven net is used for auxiliary suction, even if there are smaller thrombi that are free to the downstream branch vessels, a predetermined amount of thrombolytic anticoagulant drugs can be injected after the suction is completed to ensure the safety of the operation.

In addition, an operating handle 150 is provided at the proximal end of the sheath core 100 for the operator to hold and facilitate pushing or withdrawing the sheath assembly.

Through the above technical solution, the present application sets a collection net 210 at the front end of the sheath tube 200. The collection net 210 intercepts the broken thrombi that fall off during the suction process, which can effectively solve the risk of thrombi being retained outside the sheath tube 200. At the same time, a net storage section 120 is set at the front end of the sheath core 100. When the thrombus removal sheath tube 200 is placed in the blood vessel, there is no need to place an additional delivery sheath, and the entire process of thrombus suction can be completed only through the sheath tube 200 and the sheath core 100. Optimized the surgical procedure.

In addition, since the traditional thrombus removal sheath tube assembly 10 is usually formed by assembling multiple tubular parts, it can include a delivery sheath, a sheath tube, and a sheath core from the outside to the inside, so that the inner diameter of the inner tube cavity is smaller under the same outer diameter. Therefore, the present application adopts the design of the net-hiding segment 120, and since the collection net 210 is set at the distal end of the sheath tube 200 and the collection net 210 is accommodated by the net-hiding segment 120, the traditional delivery sheath design can be eliminated, thereby reducing the number and volume of tubular parts that penetrate the blood vessel, and can ensure the suction area of the suction cavity of the sheath tube 200, effectively improving the suction efficiency.

Embodiment 2. Embodiment 2 of the present invention provides an embolism removal sheath tube assembly 10, wherein the structure of the embolism removal sheath tube assembly 10 is shown in Figures 9 to 12. The similarities between Embodiment 2 and Embodiment 1 are not repeated here. The difference between Embodiment 2 and Embodiment 1 is that, please refer to Figure 7, the embolism removal sheath tube assembly 10 includes a sheath core 100 and a sheath tube 200, and also includes an outer sheath 300. The sheath tube 200 is arranged in the outer sheath 300 during assembly.

In this embodiment, the embolism removal sheath tube 200 further includes an outer sheath 300. By providing the outer sheath 300 on the outside of the sheath tube 200, the collecting net 210 does not need to be used in conjunction with other sheaths when being removed, thereby increasing the applicability of the embolism removal sheath tube 200.

At the same time, as shown in FIG8 and FIG9, since the distal end of the sheath core 100 is provided with a net-hiding section 120, the front end of the sheath tube 200 is provided with a collection net 210, and the collection net 210 is gathered in the net-hiding section 120 during transportation. Compared with the conventional thrombus removal sheath tube assembly 10 without the net-hiding section 120, since the sheath core 100 is not provided with the net-hiding section 120 for accommodating the collection net 210, the collection net 210 will be elastically restored during the assembly process of the sheath tube 200 and the outer sheath 300. Under the action of force, the collection net 210 will naturally expand in the outer sheath 300, and the expanded collection net 210 will be close to the inner wall of the outer sheath 300, resulting in increased friction, which increases the difficulty of assembling the sheath tube 200 and the outer sheath 300. When the outer side of the metal mesh of the collection net 210 is provided with a covering member 212 with a large friction coefficient such as silicone, the covering member 212 may even be displaced or even broken during the assembly of the sheath tube 200 and the outer sheath 300, thereby causing the collection net 210 to be poorly sealed in the blood vessel, affecting the effect of thrombus interception.

The present application improves the structure of the front end of the sheath core 100 and adds a net storage section 120 for accommodating the collecting net 210 on the sheath core 100, thereby further facilitating the assembly of the embolism removal sheath tube assembly 10 when the embolism removal sheath tube assembly 10 includes an outer sheath 300. This not only reduces the difficulty of assembling the sheath tube 200 and the outer sheath 300, but also protects the collecting net 210 and ensures the sealing performance of the collecting net 210.

In this embodiment, as shown in FIG. 10 , the first connection portion 223 is disposed at a port at the proximal end of the sheath tube 200 , and the first connection portion 223 is used as a connection component for connecting to an external negative pressure component.

The specific use process of the thrombus removal sheath tube assembly 10 is as follows: when the assembled sheath assembly enters the human body and reaches the designated part, the sheath core 100 is pushed forward to release the collection net 210 from the net storage section 120, and the outer sheath 300 is withdrawn to release the collection net 210. Then the sheath core 100 is pulled out of the sheath tube 200, and the negative pressure component is connected to the sheath tube 200 through the first connecting portion 223, and the negative pressure component is operated to perform suction. After the thrombus removal is completed, the sheath tube 200 is withdrawn to withdraw the collection net 210 into the outer sheath 300, and then the sheath tube 200 and the outer sheath 300 are withdrawn from the blood vessel together.

Further, in conjunction with FIG. 11 , the proximal end of the outer sheath 300 is provided with an outer sheath hemostatic valve 310 , one end of the outer sheath hemostatic valve 310 is fixedly connected to the outer sheath 300 , and the outer sheath hemostatic valve 310 The other end of the outer sheath 300 is provided with an insertion hole 330 for the sheath tube 200 to penetrate. During assembly, the sheath tube 200 is inserted into the outer sheath 300 from the insertion hole 330.

When the outer sheath 300 needs to be kept in the blood vessel to cooperate with other instruments, after the thrombus removal is completed, the outer sheath 300 is kept relatively still and the sheath tube 200 is withdrawn until it is withdrawn from the blood vessel. The outer sheath 300 is kept in the blood vessel as a delivery sheath to cooperate with other instruments, avoiding the step of repeatedly inserting the outer sheath 300 during the procedure, thereby optimizing the surgical process.

In other embodiments, as shown in FIG. 12 , the distal end of the sheath core 100 may not be provided with the net-hiding section 120. That is, when the distal end of the sheath core 100 is not provided with the net-hiding section 120, the collection net 210 is gathered in the outer sheath 300, and after the sheath assembly in the assembled state enters the human body and reaches the designated part, the sheath core 100 is withdrawn, and then the outer sheath 300 is withdrawn to release the collection net 210. After the thrombus removal is completed, the sheath tube 200 is withdrawn, so that the collection net 210 is withdrawn into the outer sheath 300, and then the sheath tube 200 and the outer sheath 300 are withdrawn from the human body lumen together.

In this embodiment, the net-hiding section 120 is located outside the distal end of the outer sheath 300 after assembly, or the net-hiding section 120 is located inside the outer sheath 300 after assembly. The specific position design of the net-hiding section 120 after assembly is selected according to the actual needs during the operation.

Please refer to Figures 9 and 10. The first connecting portion 223 is arranged at the port at the proximal end of the sheath tube 200. On the one hand, the first connecting portion 223 is used as a connecting component connected to an external negative pressure component. On the other hand, the first connecting portion 223 is used as a connecting component fixedly connected to the sheath core 100 when the sheath assembly penetrates the blood vessel.

The sheath core 100 is provided with a fixing member 160, which is fixedly connected to the sheath core 100 and detachably connected to the first connecting portion 223. The sheath tube 200 is provided with a positioning member 240 adapted to the fixing member 160, and the positioning member 240 is used to connect the fixing member 160 to the first connecting portion 223. It plays the role of limiting and fixing at 223.

Specifically, the first connection part 223 is an external thread formed at the proximal end of the sheath tube 200, and the distal end of the fixing member 160 is provided with a first threaded portion 161, and the distal end of the first threaded portion 161 defines an inner cavity for accommodating the first connection part 223, and the inner wall of the inner cavity is provided with an internal thread, so that the fixing member 160 is connected to the first connection part 223 by threads. The positioning member 240 is a retaining ring structure fixedly connected to the sheath tube 200. When the fixing member 160 is connected to the first connection part 223 by threaded connection, the fixing member 160 is rotated to screw the fixing member 160 toward the positioning member 240 until the distal end of the fixing member 160 is close to the proximal end of the positioning member 240, so that the fixing member 160 abuts against the positioning member 240 and is tightened and fixed.

The present application provides a fixing member 160 on the sheath core 100 to detachably connect the fixing member 160 with the first connecting portion 223 on the sheath tube 200, thereby ensuring the relative fixation of the sheath core 100 and the sheath tube 200 when the sheath assembly enters the blood vessel, thereby preventing the sheath core 100 and the sheath tube 200 from being displaced during transportation.

When the distal end of the sheath core 100 is provided with a net-hiding section 120, the sheath core 100 and the sheath tube 200 can be prevented from relative displacement during the transportation process, thereby preventing the collection net 210 from being prematurely disengaged from the net-hiding section 120. When the assembled sheath assembly reaches the predetermined position, the fixing member 160 is released from the first connecting portion 223, so that the sheath core 100 or the sheath tube 200 can be operated to release the collection net 210 from the net-hiding section 120, and the sheath core 100 can be withdrawn from the sheath tube 200 for further thrombus aspiration steps.

Furthermore, an inner sheath hemostatic valve 230 is provided on the sheath tube 200 to ensure that the gap between the sheath tube 200 and the sheath core 100 is well sealed, and when the sheath core 100 is operated to release the collecting net 210, it can be ensured that the gap between the sheath tube 200 and the sheath core 100 will not leak blood.

In addition, operating handles 150 are respectively provided at the proximal ends of the sheath core 100 , the sheath tube 200 and the outer sheath 300 , so that the operator can hold them and facilitate pushing or withdrawing the sheath assembly.

As described above, this embodiment can achieve the withdrawal of the sheath tube 200 and the sheath core 100 from the blood vessel after the thrombus aspiration process is completed through the above technical solution, but the outer sheath 300 can be retained in the blood vessel, without the need to withdraw all the instruments from the blood vessel. The outer sheath 300 retained in the blood vessel can be used as a delivery sheath when combined with other instruments for treatment, without the need to reinsert a new delivery sheath into the blood vessel, saving time, optimizing the surgical process, and improving the efficiency and success rate of the surgery.

Embodiment 3, Embodiment 3 of the present invention provides an embolism removal sheath tube assembly 10, wherein the structure of the embolism removal sheath tube assembly 10 is shown in Figures 13 to 16, and the similarities between Embodiment 3 and Embodiment 2 are not repeated, and the difference between Embodiment 3 and Embodiment 2 is that, as shown in Figures 13 and 14, a detachable outer sheath hemostatic valve 310 is provided on the outer sheath 300, and the outer sheath hemostatic valve 310 is detachably connected to the proximal end of the outer sheath 300. A developing structure 320 is provided on the sheath tube 200, and the developing structure 320 is located at the proximal end of the collection net 210.

The proximal end of the outer sheath 300 is provided with a second connection part 340, and the outer sheath hemostatic valve 310 is detachably connected to the outer sheath 300 via the second connection part 340. Specifically, the second connection part 340 is an external thread provided at the proximal end of the outer sheath 300, and the distal end of the outer sheath hemostatic valve 310 is provided with a second threaded part 311, and the distal end of the second threaded part 311 defines an inner cavity for accommodating the second connection part 340, and the inner wall of the inner cavity is provided with an internal thread, so that the second threaded part 311 is threadedly connected to the second connection part 340. A sealing ring (not shown in the figure) is also provided on the inner side of the second threaded part 311, and the sealing ring abuts against the distal end of the second connection part 340 to play a sealing role to prevent Stop bleeding.

One end of the outer sheath hemostatic valve 310 is detachable from the outer sheath 300 , and the other end of the outer sheath hemostatic valve 310 is provided with an insertion hole 330 for the sheath tube 200 to penetrate. During assembly, the sheath tube 200 is inserted into the outer sheath 300 from the insertion hole 330 .

The developing structure 320 may be a material having developing properties such as tantalum material or platinum material. The developing structure 320 includes a first developing point 321 fixedly arranged at the proximal end of the collecting net 210, and/or a developing ring 322 arranged on the sheath tube 200 and located at the proximal end of the collecting net 210. When the developing structure 320 is the developing ring 322, the developing ring 322 may be fixed on the sheath tube 200 by embedding.

In addition, the developing structure 320 also includes a second developing point 323 disposed on the collection net 210, and the second developing point 323 is disposed at the distal end of the collection net 210. The distal end of the collection net 210 is provided with at least two circumferentially arranged second developing points 323. By setting the second developing points 323, the user can clearly judge the state of the collection net 210 being deployed and recovered during operation, thereby knowing the wall-attached state of the collection net 210 when deployed and the position of the distal end of the collection net 210 when recovered. In this embodiment, a plurality of second developing points 323 are evenly distributed along the circumference of the distal end of the collection net 210.

Specifically, please refer to 15 and 16. When the thrombus removal sheath tube 200 is used, the assembled sheath assembly is passed along the guide wire into the blood vessel to reach the target lesion position, the sheath tube 200 and the outer sheath 300 are fixed, and the sheath core 100 is pushed forward to release the collection net 210. The sheath core 100 is removed and the sheath tube 200 and the outer sheath 300 are retained in the blood vessel to cooperate with suction, balloon or stent thrombus removal.

When the thrombus removal is completed, the outer sheath 300 is fixed and the sheath tube 200 is pulled backward to collect the net 210 . When the collecting net 210 is withdrawn, when the sheath tube 200 is withdrawn to the point where the first developing point 321 can be seen, it can be determined that the collecting net 210 is already at the outer sheath hemostatic valve 310. At this time, the outer sheath hemostatic valve 310 is removed and the collecting net 210 is taken out, and the outer sheath 300 is retained in the blood vessel and continues to be used as a sheath in conjunction with other instruments for treatment. After the collecting net 210 is taken out, the outer sheath hemostatic valve 310 is reinstalled on the outer sheath 300 to prevent the outer sheath 300 from leaking blood.

If thrombus removal is required again, the sheath core 100 is inserted into the sheath tube 200, and the collection net 210 is loaded into the sheath core 100 and the net section 120, and then the sheath core 100 is inserted into the outer sheath 300 again along the guide wire, and the collection net 210 is brought into the target blood vessel and released. At this time, the position of the second imaging point 323 can be observed to determine the state of the collection net 210 being deployed, so as to ensure the smooth progress of the operation.

Furthermore, an inner sheath hemostatic valve 230 is provided at the proximal end of the sheath tube 200 to ensure that the gap between the sheath tube 200 and the sheath core 100 is well sealed, and when the sheath core 100 is operated to release the collection net 210, the gap between the sheath tube 200 and the sheath core 100 will not leak blood. In this embodiment, the inner sheath hemostatic valve 230 is detachably connected to the sheath tube 200.

Specifically, please refer to FIG. 14 , the first connection part 223 is disposed at the port at the proximal end of the sheath tube 200, and the first connection part 223 of the inner sheath hemostatic valve is used as a connection component that is detachably connected to the inner sheath hemostatic valve 230 during the sheath assembly delivery process. When the sheath assembly is delivered to a preset position, the inner sheath hemostatic valve 230 on the sheath tube 200 is first removed, and then the external negative pressure component is connected to the first connection part 223, and thrombus aspiration is performed through the external negative pressure component.

Since the sheath tube 200 is a suction lumen during thrombus aspiration, the detachable inner sheath hemostatic valve 230 can ensure the inner lumen area of the sheath tube 200, provide a larger suction lumen, and improve the thrombus aspiration effect.

As described above, this embodiment realizes visualization during the operation through the above technical solution. During the operation, the user can clearly judge the state of the collection net 210 being deployed and recovered, thereby knowing the wall-attached state of the collection net 210 when deployed and the position of the distal end of the collection net 210 when recovered. In addition, the structural design of the detachable hemostatic valve facilitates the withdrawal and secondary suction of the sheath tube 200.

Embodiment 4. Embodiment 4 of the present invention provides a thrombus removal sheath tube assembly 10, wherein the structure of the thrombus removal sheath tube assembly 10 is shown in Figures 17 to 20. The similarities between Embodiment 4 and Embodiment 2 are not repeated here. The difference between Embodiment 4 and Embodiment 2 is that, as shown in Figures 17 and 19, an outer sheath 300 is provided on the outer side of the sheath tube 200, and a collection net 210 is provided at the distal end of the outer sheath 300, wherein the collection net 210 is fixedly connected to the distal end of the outer sheath 300. The collection net 210 includes a net body 211 having shape memory properties. A net storage section 120 for accommodating the collection net 210 is provided on the sheath tube 200. The net storage section 120 is provided between the sheath tube 200 and the outer sheath 300, wherein the distal end thereof is connected to the distal end of the sheath tube 200, and the proximal end thereof is connected to the outer sheath 300.

The network-hidden segment 120 includes a proximal network-hidden segment 123 and a distal network-hidden segment 124 which are connected to each other. The proximal network-hidden segment 123 is connected to the outer sheath 300 , and the distal network-hidden segment 124 is connected to the sheath tube 200 .

Further, one end of the distal network segment 124 is connected to the distal end of the sheath tube 200, and the other end of the distal network segment 124 is fixedly connected to the proximal network segment 123, and the proximal end of the proximal network segment 123 is connected to the distal end of the outer sheath 300. 124 is closed and connected, and the closed interior forms a receiving cavity (not marked in the figure) for accommodating the net body 211.

The net body 211 may be a metal net with memory properties, such as a metal net woven from nickel-titanium wires. The net body 211 is woven and formed by the braiding wires 213 and then heat-treated to form a shape, and has elastic memory properties. The net-hiding section 120 covers the net body 211 inside, and the net-hiding section 120 is a membrane structure with good elastic properties. Thus, the operator can control the unfolding state of the net body 211 by manipulating the shape of the net-hiding section 120.

It can be understood that the proximal network segment 123 and the distal network segment 124 can be set as one piece or separately, the proximal network segment 123 can be fixedly connected to the network body 211 or movably connected in a separate body, and the materials of the proximal network segment 123 and the distal network segment 124 can be the same or different.

Specifically, when the proximal net-hiding segment 123 and the distal net-hiding segment 124 are integrally arranged, the proximal net-hiding segment 123 and the distal net-hiding segment 124 are made of the same material. In this embodiment, the net-hiding segment 120 is a balloon with good telescopic performance, such as a silicone balloon. When the balloon is formed, the net body 211 is arranged inside the balloon to form a whole. At this time, the net body 211 and the net-hiding segment 120 are separately and movably connected.

When the proximal web-hiding segment 123 and the distal web-hiding segment 124 are separately provided, the materials of the proximal web-hiding segment 123 and the distal web-hiding segment 124 can be the same or different, and specifically can be one or more of polyethylene (PE), polyurethane, and nylon. At this time, after the proximal web-hiding segment 123 and the distal web-hiding segment 124 are formed separately, the net body 211 is arranged inside the proximal web-hiding segment 123, and then the proximal web-hiding segment 123 and the distal web-hiding segment 124 are hot-fused to form a whole.

When the proximal web-hiding segment 123 and the distal web-hiding segment 124 are separately provided, the net body 211 can be fixedly connected or movably connected to the proximal web-hiding segment 123. If the net body 211 and the proximal web-hiding segment 123 are fixedly connected, the proximal web-hiding segment 123 is a coating structure coated on the net body 211.

It is understandable that in another embodiment of the present application, the collection net 210 further includes a covering member 212 disposed on the net body 211, the covering member 212 covers the mesh of the net body 211, and the covering member 212 is a coating structure covering the net body 211. The material of the net segment 120 and the covering member 212 can be the same or different. By arranging the covering member 212 on the net body 211, the net body 211 is more uniform when deformed. In addition, when the net body 211 is unfolded, it will not directly contact the net segment 120, but will contact the net segment 120 through the softer covering member 212, so that the net segment 120 will not be damaged due to excessive deformation of the net body 211 or too fast deformation speed, thereby improving the safety of the overall component.

Through the above-mentioned technical scheme, the present application can control the size of the filled network segment 120, control the diameter of the released network body 211, and adjust the filling shape of the network segment 120 by controlling the relative position of the sheath tube 200 and the outer sheath 300, thereby achieving the purpose of adapting to blood vessels of various diameters with only one size of collection network 210.

Since the conventional thrombectomy sheath tube assembly 10 is formed by assembling multiple tubular parts, for example, the thrombectomy sheath tube assembly 10 of the present application includes an outer sheath 300, a sheath tube 200, and a sheath core 100 from the outside to the inside, so that the inner diameter of the inner tube cavity is smaller under the same outer diameter. At the same time, a collection net 210 of one specification can only correspond to a blood vessel of one diameter. If the blood vessel is too large, it cannot be sealed. If the blood vessel is too small, the collection net 210 is easily released to form a gap between the cover 212 and the blood vessel, affecting the sealing effect.

In this embodiment, a net-hiding segment 120 with good elasticity is arranged on the outside of the net body 211. By controlling the shape and size of the net-hiding segment 120, the diameter of the collection net 210 when released is indirectly controlled, so that the collection net 210 of the same specification can be adapted to blood vessels of various diameters. The net-hiding segment 120 of this embodiment specifically adopts a silicone balloon. Since the silicone balloon has a large contraction force, it can effectively compress the diameter of the metal net, so that the product has a larger inner diameter under the same outer diameter.

As shown in FIG. 19 and FIG. 20 , one end of the net-hiding segment 120 is connected to the outer sheath 300, and the other end of the net-hiding segment 120 is connected to the sheath tube 200. The net body 211 is arranged inside the net-hiding segment 120, and the axial length of the net body 211 is less than the axial length of the entire net-hiding segment 120. The net body 211 is in a shape of proximal contraction and distal expansion. In this embodiment, the net body 211 is in a trumpet shape. The ratio of the axial length of the net body 211 in a fully expanded state to the axial length of the net-hiding segment 120 in a filled state is 1:4 to 3:4.

Furthermore, an outer sheath hemostatic valve 310 is provided at the proximal end of the outer sheath 300 , an extension tube 350 is provided at the proximal end of the outer sheath hemostatic valve 310 , and the distal end of the sheath tube 200 passes through the extension tube 350 and penetrates into the inner part of the outer sheath 300 .

In this embodiment, a locking member 260 is provided on the sheath tube 200, and a locking connection portion 351 is provided at the proximal end of the extension tube 350. The locking connection portion 351 is locked and connected with the locking member 260 so that the sheath tube 200 and the outer sheath 300 remain relatively fixed. Among them, the locking connection portion 351 is an external thread structure fixedly provided at the proximal end of the extension tube 350, and the locking member 260 is connected to the locking connection portion 351 by threads, and the locking member 260 is rotatably connected to the sheath tube 200. In this embodiment, a protrusion is provided on the locking member 260, and an annular groove for clamping the protrusion is provided on the sheath tube 200 (the protrusion and the annular groove are not shown in the figure), so that the locking member 260 It can rotate relative to the sheath tube 200 but cannot move axially.

In other embodiments, the locking member 260 and the locking connection portion 351 may also be connected by hook engagement, or other detachable connection methods may be used.

In this embodiment, during the transportation of the sheath assembly, the locking piece 260 is fixed on the locking connection part 351 to relatively fix the outer sheath 300 and the sheath tube 200. When the locking piece 260 is fixed on the locking connection part 351, the net hiding segment 120 is in the shape of a long strip. When the filling medium is not injected into the net hiding segment 120, the net hiding segment 120 and the collecting net 210 are attached to the outer wall of the sheath tube 200 under the action of tension.

When the locking member 260 is unlocked from the locking connection portion 351, the locking connection between the outer sheath 300 and the sheath tube 200 is released accordingly, and the operator can control the filling state of the net-hiding segment 120 by injecting a filling medium into the net-hiding segment 120. The filling medium can be gas or liquid. When the net body 211 is unfolded, the operator can move the outer sheath 300 or the sheath tube 200 to change the shape of the net-hiding segment 120.

In this embodiment, when the outer sheath 300 and the sheath tube 200 are unlocked, the sheath tube 200 is withdrawn relative to the outer sheath 300, so that the distal net-hiding segment 124 moves toward the proximal end relative to the distal end of the outer sheath 300, until the net-hiding segment 120 gradually changes from an approximately elliptical shape to an approximately trumpet shape, and forms a trumpet shape that matches the net body 211. In this state, the operator can further adjust the relative hardness of the net-hiding segment 120 by injecting or withdrawing the filling medium inside the net-hiding segment 120 to adjust the wall adhesion of the net body 211.

Subsequently, the sheath core 100 is withdrawn from the human blood vessel, and a suction cavity 270 is formed inside the sheath tube 200, as shown in Figure 18. The external negative pressure component is connected to the first connection portion 223 at the proximal end of the sheath tube 200, and the blood clot in the blood vessel is suctioned by the external negative pressure component.

Specifically, when the thrombus removal sheath tube assembly 10 of this embodiment is used, the thrombus removal sheath tube assembly 10 in the combined state is first introduced into the blood vessel along the guide wire to reach the target lesion position. The degree of filling of the net segment 120 is selected according to the diameter of the blood vessel, so that the net body 211 opens under the action of its own elastic restoring force and is close to the inner wall of the net segment 120. Then, the locking structure between the sheath tube 200 and the outer sheath 300 is loosened to keep the outer sheath 300 relatively fixed, and the sheath tube 200 is moved backward relative to the sheath tube 200, so that the net segment 120 forms a trumpet shape that matches the net body 211. Finally, the sheath core 100 is withdrawn, and the end of the sheath tube 200 is connected to the inner sheath hemostatic valve 230, and the thrombus is removed by extraction or stent thrombus removal.

After the suction is completed, the sheath tube 200 is moved toward the direction of the distal end of the outer sheath 300, and the filling medium inside the net-hiding section 120 is extracted, and then the locking member 260 is re-fixedly connected with the locking connection portion 351 to achieve relative locking of the sheath tube 200 and the outer sheath 300. At this time, the net-hiding section 120 is re-attached to the outer wall of the sheath tube 200, and the sheath tube 200 and the outer sheath 300 can be withdrawn from the blood vessel. The shape of the net-hiding section 120 attached to the sheath tube 200 is shown in FIG. 17 .

In summary, this embodiment controls the diameter of the net body 211 by setting a retractable net segment 120 outside the net body 211 and controlling the filling state of the net segment 120, thereby achieving the purpose of using a net body 211 of one specification to adapt to blood vessels of various diameters. At the same time, during the delivery process, the net body 211 can be compressed by the net segment 120, which facilitates the sheath assembly to penetrate the blood vessel after assembly.

Embodiment 5, Embodiment 5 of the present invention provides a thrombus removal sheath tube assembly 10, wherein the structure of the thrombus removal sheath tube assembly 10 is shown in Figures 22 to 27, and Embodiment 5 is similar to Embodiment 2. The similarities of Example 1 are not repeated here. The difference between Example 5 and Example 1 is that, as shown in FIG. 22 and FIG. 23, the thrombus removal sheath tube assembly 10 includes a sheath tube 200 and a sheath core 100. The sheath core 100 is inserted into the sheath tube 200. The distal end of the sheath tube 200 is provided with a collection net 210. The collection net 210 is used to intercept thrombi to prevent the broken thrombi that have not been successfully aspirated from entering the downstream branch blood vessels during the thrombus aspiration process, causing secondary embolism. Among them, the distal end of the sheath tube 200 is provided with a net storage section 120 for storing the collection net 210. When the sheath tube 200 is placed in the blood vessel, the collection net 210 is stored in the net storage section 120. After the sheath tube 200 moves to the target position, the collection net 210 is released from the net storage section 120.

As shown in FIGS. 23 and 24 , a tail piece 220 is provided at the proximal end of the sheath tube 200. The sheath tube 200 includes an inner tube 280 and an outer tube 290. The outer tube 290 is sleeved on the outer side of the inner tube 280. The inner tube 280 and the outer tube 290 can move relative to each other in the axial direction. The collecting net 210 is fixedly connected to the distal end of the inner tube 280, and the net-hiding section 120 is provided on the inner side of the distal end of the outer tube 290. The tail piece 220 includes a control rod 224, a catheter seat 226 provided at the proximal end of the control rod 224, and a control piece 225 provided on the control rod 224. The control piece 225 is used to control the relative movement of the inner tube 280 and the outer tube 290.

In this embodiment, the control member 225 is a knob 2251, which is rotatably connected to the control rod 224. The inner tube 280 and the outer tube 290 are respectively connected to the catheter seat 226 and the knob 2251. The knob 2251 has a hollow inner cavity and is rotatably connected to the control rod 224, the outer tube 290 is fixedly connected to the inner cavity of the knob 2251, and the inner tube 280 passes through the outer tube 290 and is inserted into the catheter seat 226.

A threaded connection portion 291 is provided between the inner tube 280 and the outer tube 290, wherein the inner wall of the outer tube 290 is provided with an internal thread, and the outer wall of the inner tube 280 is provided with an external thread. The inner tube 280 is connected to the outer tube 290 by threads. A guide portion 227 is provided between the inner tube 280 and the catheter seat 226, wherein a guide block 2271 is provided on the inner tube 280, and a guide groove 2272 is provided on the inner wall of the catheter seat 226. The guide block 2271 slides along the guide groove 2272, so that the inner tube 280 can move along the axial direction of the catheter seat 226, but cannot rotate around the circumferential direction of the catheter seat 226.

When the collection net 210 is contained in the net storage section 120 of the outer tube 290, the collection net 210 will cling to the inner wall of the net storage section 120 under the action of its own elastic restoring force, so when the collection net 210 is pushed out of the outer tube 290, it is necessary to overcome the friction between the collection net 210 and the net storage section 120. By rotating the knob 2251 to release the collection net 210, the rotation of the knob 2251 is converted into the translation of the outer tube 290, so that it is more labor-saving when releasing.

In this embodiment, the internal thread on the outer tube 290 and the external thread on the inner tube 280 are self-locking threaded. Through the self-locking connection of the internal and external threads, the inner tube 280 and the outer tube 290 can be accurately positioned, and the proportion of the collection net 210 extending out of the outer tube 290 can be controlled to adapt to blood vessels with different inner diameters. In addition, it can avoid accidental touch by the operator, ensure the stability of the state of the collection net 210 during the suction process, and improve the success rate of the operation.

Among them, the net storage section 120 is an annular groove body 130 arranged on the inner wall of the distal end of the outer tube 290. When the collection net 210 is stored in the outer tube 290, the annular groove body 130 provides a storage space for the collection net 210. Among them, the annular groove body 130 can be annular or conical. In the present embodiment, the annular groove body 130 is conical, and the inner diameter of the annular groove body 130 gradually increases from the proximal end to the distal end. Through the above design, the net storage section 120 can accommodate the collection net 210, and the design of the conical cross section can make the process of releasing and recovering the collection net 210 smoother, thereby improving the efficiency and success rate of releasing and recovering the collection net 210.

When the thrombus removal sheath tube assembly 10 of this embodiment is used, the thrombus removal sheath tube assembly 10 in the combined state is first introduced into the blood vessel along the guide wire to reach the target lesion position, and then the sheath core 100 is withdrawn and the collection net 210 is released. When releasing the collection net 210, the operator drives the outer tube 290 to rotate synchronously by rotating the knob 2251, and through the threaded fit, the inner tube 280 moves toward the distal end along the axial direction of the outer tube 290. The collection net 210 gradually moves out of the net storage section 120 as the inner tube 280 moves, and unfolds under the action of its own elastic restoring force. The operator can select the length of the collection net 210 extending out of the sheath tube 200 according to the diameter of the patient's blood vessel, thereby controlling the size of the collection net 210. After the collection net 210 is released and close to the inner wall of the blood vessel, the external negative pressure component is connected to the tail end piece 220, and the thrombus in the blood vessel is sucked out by the external negative pressure component.

When the suction is completed, the collection net 210 is first recovered into the net storage section 120 in the sheath tube 200, and then the sheath tube 200 is withdrawn from the blood vessel. When recovering the collection net 210, the operator drives the outer tube 290 to rotate in the opposite direction by rotating the knob 2251 in the reverse direction, and through threaded engagement, the inner tube 280 moves toward the proximal end along the axial direction of the outer tube 290. The collection net 210 gradually retracts into the net storage section 120 as the inner tube 280 moves, and is accommodated in the net storage section 120 under the squeezing action of the outer tube 290.

The tail piece 220 also includes a suction port 222, which is disposed at a port at the proximal end of the catheter seat 226. The suction port 222 includes a first connection portion 223, which is used to connect with an external negative pressure component. During assembly, the sheath core 100 passes through the catheter seat 226 from the suction port 222 and passes through the inner tube 280. During suction, the sheath core 100 is withdrawn from the sheath tube 200, and the external negative pressure component is connected to the first connection portion 223, and the suction step is performed.

The tail piece 220 also includes an inner sheath hemostatic valve 230 to ensure that the gap between the sheath tube 200 and the sheath core 100 is well sealed. In this embodiment, the inner sheath hemostatic valve 230 is used to close the inner tube 280 and the sheath core 100, so that when the sheath core 100 is operated, the gap between the inner tube 280 and the sheath core 100 is guaranteed not to leak blood.

In other embodiments, as shown in FIG25 , the outer tube 290 can also be fixedly connected to the control rod 224, and the inner tube 280 passes through the proximal end of the outer tube 290 and is threadedly connected to the knob 2251. When the knob 2251 is turned, the inner tube 280 can be driven to move axially, thereby releasing or recovering the collection net 210. The fixed connection between the outer tube 290 and the control rod 224 can ensure that the outer tube 290 and the inner wall of the blood vessel remain stable during the release or recovery of the collection net 210, thereby preventing the outer tube 290 from scratching the blood vessel during the operation.

Among them, a connecting tube 281 is provided at the distal end of the inner tube 280, and the connecting tube 281 is embedded in the distal end of the inner tube 280, thereby enhancing the strength of the distal end of the inner tube 280, so that the collecting net 210 is more stable during the pushing process.

In other embodiments, as shown in FIG26 , the control member 225 can also be a sliding button 2252 disposed on the control rod 224, and the inner tube 280 and the outer tube 290 are respectively connected to the catheter seat 226 and the sliding button 2252. The inner tube 280 is fixedly connected to the catheter seat 226, the outer tube 290 is fixedly connected to the sliding button 2252, and the sliding button 2252 is slidably connected to the control rod 224. When the operator moves the sliding button 2252, the outer tube 290 slides synchronously with the sliding button 2252, thereby releasing or recovering the collection net 210. The slidingly connected inner tube 280 and outer tube 290 fit more closely, can provide better sealing performance, and improve the anti-leakage performance of the tail piece 220.

The present application adopts the above technical solution, and the collecting net 210 and the net storage section 120 are integrated on the sheath tube 200, and the collecting net 210 intercepts the broken plugs that fall off during the suction process, which can effectively The risk of thrombus retention outside the sheath tube 200 is effectively solved. At the same time, the design of the net section 120 makes it unnecessary to insert an additional delivery sheath during the process of inserting the thrombus removal sheath tube 200 into the blood vessel, and the entire process of thrombus aspiration can be completed only through the sheath tube 200 and the sheath core 100, thereby optimizing the surgical process.

In other embodiments, as shown in FIG. 27 , the thrombus removal sheath assembly 10 may further include an outer sheath 300, which is sleeved on the outside of the sheath 200. By arranging the outer sheath 300 on the outer sheath of the sheath 200, when the thrombus removal sheath assembly 10 is used to aspirate thrombi or plaques in the main branch blood vessels, the thrombus removal sheath assembly 10 with the outer sheath 300 can improve the overall strength of the thrombus removal sheath assembly 10, avoid excessive deformation of the sheath 200 due to passing through the bend of the blood vessel, ensure the suction area of the inner cavity of the sheath 200, and ensure the efficiency and success rate of thrombus aspiration. During the actual operation, the operator can choose to insert only the sheath 200 according to the actual situation, or choose to insert the outer sheath 300 and the sheath 200 at the same time.

Embodiment 6. Embodiment 6 of the present invention provides a thrombus removal sheath tube assembly 10, wherein the structure of the thrombus removal sheath tube assembly 10 is shown in Figures 28 to 33. The similarities between Embodiment 6 and Embodiment 5 are not repeated here. The difference between Embodiment 6 and Embodiment 5 is that, as shown in Figures 28 and 29, the thrombus removal sheath tube assembly 10 includes a sheath tube 200 and a sheath core 100, the sheath core 100 is inserted into the sheath tube 200, and a collection net 210 and a net storage segment 120 are provided on the sheath tube 200. The collection net 210 is provided at the distal end of the sheath tube 200, and the net storage segment 120 includes an annular groove body 130 provided on the inner wall of the distal end of the sheath tube 200. When the sheath tube 200 is placed in a blood vessel, the collection net 210 is accommodated in the net storage segment 120, and after the sheath tube 200 moves to the target position, the collection net 210 is released from the net storage segment 120.

The proximal end of the sheath tube 200 is provided with a tail piece 220, and a control wire 228 is passed through the tube wall of the sheath tube 200, one end of the control wire 228 is connected to the tail piece 220, and the other end of the control wire 228 is connected to the collection net 210, and the control wire 228 is used to control the shape of the collection net 210. In this embodiment, a control cavity 229 is buried in the tube wall of the sheath tube 200, and the control wire 228 is passed through the control cavity 229. Among them, multiple groups of control wires 228 are provided in the sheath tube 200.

In this embodiment, as shown in FIG30 , three groups of control wires 228 are provided in the sheath tube 200 to make the collection net 210 more evenly and stably stressed during the recovery and release process. It is understood that in other embodiments, as shown in FIG31 , four or more groups of control wires 228 may be provided in the sheath tube 200.

The tail piece 220 includes a control rod 224 , a catheter seat 226 disposed at the proximal end of the control rod 224 , and a control piece 225 disposed on the control rod 224 . The control piece 225 is used to adjust the axial movement of the control wire 228 , thereby adjusting the shape of the collection net 210 .

The control member 225 includes a knob 2251 rotatably connected to the control rod 224 and a control block 2253 connected to the knob 2251. The control block 2253 is threadedly connected to the knob 2251, and the control block 2253 is slidably connected to the control rod 224, and one end of the control wire 228 is fixedly connected to the control block 2253. Rotating the knob 2251 can drive the control block 2253 to slide along the control rod 224, thereby operating the control wire 228.

In other embodiments, as shown in FIG. 32 , the control member 225 may further include a slide button 2252 slidably connected to the control rod 224 , and the control wire 228 is fixedly connected to the slide button 2252 , and the slide button 2252 is pushed to move along the control rod 224 , thereby operating the control wire 228 .

As shown in FIG. 29 , in this embodiment, the collection net 210 includes a closed end 214 and an open end 215. The closed end 214 of the collection net 210 is connected to the sheath tube 200. The open end 215 of the collection net 210 is connected to the control wire 228 at the distal end thereof. Since the control block 2253 is threadedly connected to the knob 2251, when the knob 2251 is rotated, the control block 2253 will move axially with the rotation of the knob 2251, thereby driving the control wire 228 to move axially, thereby being able to control the shape of the collection net 210.

When the collection net 210 is controlled to be in an expanded state, as shown in FIG29, the knob 2251 is rotated to move the control block 2253 toward the distal end of the control rod 224, and the distal end of the control wire 228 moves toward the distal end along with the movement of the control block 2253. The collection net 210 gradually extends out of the net-hiding section 120 under the action of its own elastic restoring force and returns to a naturally expanded state. When the control block 2253 moves to the distal end of the control rod 224, the control wire 228 has no pulling force on the collection net 210. At this time, the collection net 210 returns to a naturally expanded state under the action of its own elastic restoring force to seal the blood vessel lumen.

When the collection net 210 is controlled to be in the receiving state, as shown in FIG33 , the knob 2251 is rotated to move the control block 2253 toward the proximal end of the control rod 224, and the distal end of the control wire 228 moves toward the proximal end of the sheath tube 200 along with the movement of the control block 2253. Since the control wire 228 is connected to the open end 215 of the collection net 210, the open end 215 of the collection net 210 moves toward the proximal end of the sheath tube 200 under the pulling action of the control wire 228 during the process of the control wire 228 moving toward the proximal end of the sheath tube 200, and gradually retracts into the net storage section 120. When the control block 2253 moves to the proximal end of the control rod 224, the collection net 210 will fit into the net storage section 120 under the pulling action of the control wire 228.

In this embodiment, the axial length of the collection net 210 is less than or equal to the radius of the inner cavity of the sheath tube 200. This ensures that the collection net 210 can be freely accommodated or deployed without being stuck in the sheath tube 200, thereby improving the efficiency and success rate of the operation.

In other embodiments, the axial length of the collecting net 210 may also be greater than the inner cavity of the sheath tube 200, and the hardness of the control wire 228 may be greater than the hardness of the collecting net 210, so that during the process of receiving or deploying the collecting net 210, the pulling force or pushing force of the control wire 228 on the collecting net 210 is greater than the friction force between the collecting net 210 and the sheath tube 200, thereby ensuring that the collecting net 210 can be smoothly received or deployed.

Through the above technical solution, the present application integrates the collection net 210 and the net storage section 120 on the sheath tube 200. The collection net 210 intercepts the broken thrombi that fall off during the suction process, which can effectively solve the risk of thrombi being retained outside the sheath tube 200. At the same time, the design of the net storage section 120 makes it unnecessary to insert an additional delivery sheath during the process of inserting the thrombus removal sheath tube 200 into the blood vessel, and the entire process of thrombus suction can be completed only through the sheath tube 200 and the sheath core 100, thereby optimizing the surgical process.

The above is only a preferred specific implementation of the present invention, but the protection scope of this application is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed in this application should be included in the protection scope of this application. Therefore, the protection scope of this application should be based on the protection scope of the claims.

Claims

A thrombus removal sheath tube assembly comprises a sheath tube and a sheath core, wherein the sheath core is inserted into the sheath tube, and is characterized in that a collecting net is arranged at the distal end of the sheath tube, and a net storage section for accommodating the collecting net is arranged on the sheath tube.
The embolus removal sheath tube assembly according to claim 1 is characterized in that the proximal end of the collecting net is closed and fixedly connected to the distal end of the outer sheath, and the distal end of the collecting net is open.
The embolus removal sheath tube assembly according to claim 2 is characterized in that the collection net includes a net body with shape memory properties and a covering member arranged on the net body, and the covering member covers the mesh of the net body.
The embolus removal sheath tube assembly according to claim 1 is characterized in that a tail end piece is provided at the proximal end of the sheath tube, and the tail end piece includes a control piece for adjusting the posture of the collection net.
The embolism removal sheath tube assembly according to claim 4 is characterized in that the tail end piece also includes a control rod and a catheter seat connected to the proximal end of the control rod, the control piece is arranged on the control rod and connected to the sheath tube, and the sheath tube passes through the control rod and is connected to the catheter seat.
The embolus removal sheath tube assembly according to claim 5 is characterized in that the catheter seat is provided with a suction port for connecting an external negative pressure component and an inner sheath hemostatic valve.
The embolus removal sheath tube assembly according to claim 5 is characterized in that the sheath tube comprises an inner tube and an outer tube sleeved outside the inner tube, the inner tube and the outer tube can move relative to each other in the axial direction, the collecting net is arranged at the distal end of the inner tube, and the net storage section is arranged on the inner side of the distal end of the outer tube; the control member is used to control the inner tube and the outer tube Relative movement.
The embolus removal sheath tube assembly according to claim 7, characterized in that the control member comprises a knob rotatably connected to the control rod, the outer tube is fixedly connected to the control rod, the inner tube is threadedly connected to the knob, and the inner tube passes through the outer tube and is slidably connected to the catheter seat; or

The control member comprises a knob rotatably connected to the control rod, the outer tube is fixedly connected to the knob, the inner tube is threadedly connected to the outer tube, and the inner tube passes through the outer tube and is slidably connected to the catheter seat; or

The control member comprises a sliding knob slidably connected to the control rod, the outer tube is fixedly connected to the sliding knob, the inner tube is slidably connected to the outer tube, and the inner tube passes through the outer tube and is fixedly connected to the catheter seat.
The embolus removal sheath tube assembly according to claim 7 is characterized in that the net hiding section includes an annular groove body arranged on the inner side of the distal end of the outer tube.
The embolus removal sheath assembly according to claim 5 is characterized in that a control wire is passed through the sheath, one end of the control wire is connected to the collecting net, and the other end of the control wire is connected to the control member, and the control member adjusts the shape of the collecting net through the control wire.
The embolus removal sheath tube assembly according to claim 10, characterized in that the control member comprises a knob rotatably connected to the control rod and a control block, the control block is threadedly connected to the knob and slidably connected to the control rod, one end of the control wire is connected to the control block, and the sheath tube is fixedly connected to the control rod; or

The control member includes a sliding torsion bar slidably connected to the control rod, and the control wire One end is connected to the control block, and the sheath is fixedly connected to the control rod.
The embolus removal sheath assembly according to claim 10 is characterized in that the axial length of the collecting net is less than or equal to the radius of the inner diameter of the sheath; or the axial length of the collecting net is greater than the radius of the inner diameter of the sheath, and the hardness of the control wire is greater than the hardness of the collecting net.
The embolus removal sheath assembly according to claim 10 is characterized in that the net hiding section includes an annular groove body arranged on the inner side of the distal end of the sheath, a control cavity is arranged in the tube wall of the sheath, and the control wire is passed through the control cavity.